- TessArray Resequencing Pathogen Microarray is a new technology that can identify multiple infectious agents in a single specimen. Researchers are interested in determining whether the technology can accurately identify the germs responsible for causing respiratory infections. Respiratory samples, such as sputum or cells and fluid from the lungs, will be collected and studied using this technique.

Objectives:

- To evaluate the effectiveness of using TessArray Resequencing Pathogen Microarray to examine and identify infectious agents in respiratory samples.

Eligibility:

- Individuals at least 2 years of age who are having respiratory samples collected as part of a doctor's evaluation.

Design:

Participants will be selected from individuals who are providing respiratory samples as part of treatment for an infection or for other medical reasons. A portion of the respiratory sample collected will be used for research purposes.

Participants will provide a blood sample during or up to 3 days before or after the collection of the respiratory sample.

Participants may be asked to provide a second blood sample 2 to 12 weeks after the first sample is taken.

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections. [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:

250

Study Start Date:

September 2010

Detailed Description:

Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.

The TessArray -Resequencing Pathogen Microarray (RPM) technology (from TessArae , LLC) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), the TessArray microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.

Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the TessArray microarray. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.

The results of the TessArray microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.

Eligibility

Ages Eligible for Study:

2 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

Subjects may be included in this study if they:

Are 2 years of age and older.

Are being evaluated for a respiratory infection.

Are having respiratory specimens collected as part of their clinical evaluation.

Agree to have specimens stored for future research.

EXCLUSION CRITERIA:

Patients unable or unwilling to give informed consent will be excluded from the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212042